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Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements

Document ID: FDA-2008-N-0334-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: E9-19682
CFR Citation: 21 CFR 600;314;21 CFR 310
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Details Information

Document Subtype: NPR-Notice of Proposed Rule-Making
Received Date: August 20 2009, at 12:08 PM Eastern Daylight Time
Start-End Page: 42184 - 42203
Page Count: 20
Comment Start Date: August 21 2009, at 12:00 AM Eastern Standard Time
Comment Due Date: November 19 2009, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 7
jean public - Comment
Posted: 08/24/2009     ID: FDA-2008-N-0334-0002

Nov 19,2009 11:59 PM ET
Consumer Healthcare Products Association (CHPA) - Comment
Posted: 11/10/2009     ID: FDA-2008-N-0334-0003

Nov 19,2009 11:59 PM ET
Merck & Co., Inc. - Comment
Posted: 11/10/2009     ID: FDA-2008-N-0334-0004

Nov 19,2009 11:59 PM ET
Biotechnology Industry Organization (BIO) - Comment
Posted: 11/19/2009     ID: FDA-2008-N-0334-0005

Nov 19,2009 11:59 PM ET
K & L Gates LLP - Comment
Posted: 11/19/2009     ID: FDA-2008-N-0334-0006

Nov 19,2009 11:59 PM ET

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